ESTRADIOL; NORETHINDRONE ACETATE - Generic Drug Details

What are the generic sources for estradiol; norethindrone acetate and what is the scope of freedom to operate?

Estradiol; norethindrone acetate is the generic ingredient in six branded drugs marketed by Noven Pharms Inc, Amneal, Lupin Ltd, Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Teva Pharms Usa, Xiromed, Aurobindo Pharma Ltd, and Sumitomo Pharma, and is included in eleven NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nine suppliers are listed for this compound.

Summary for ESTRADIOL; NORETHINDRONE ACETATE

US Patents:	7
Tradenames:	6
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	9
Clinical Trials:	36
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ESTRADIOL; NORETHINDRONE ACETATE
DailyMed Link:	ESTRADIOL; NORETHINDRONE ACETATE at DailyMed

Recent Clinical Trials for ESTRADIOL; NORETHINDRONE ACETATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bio Genuine (Shanghai) Biotech Co., Ltd.	Phase 3
University of Chicago	Phase 4
Myovant Sciences GmbH	Phase 4

See all ESTRADIOL; NORETHINDRONE ACETATE clinical trials

Pharmacology for ESTRADIOL; NORETHINDRONE ACETATE

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ESTRADIOL; NORETHINDRONE ACETATE

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for ESTRADIOL; NORETHINDRONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xiromed	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	207261-002	Feb 10, 2017	AB	RX	No	No
Xiromed	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	207261-001	Feb 10, 2017	AB	RX	No	No
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	AB	RX	Yes	Yes
Sumitomo Pharma	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	11,957,684
Teva Pharms Usa	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	200747-001	Mar 8, 2012		DISCN	No	No
Sumitomo Pharma	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes

Expired US Patents for ESTRADIOL; NORETHINDRONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998	5,474,783
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	RE36247
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-001	Aug 7, 1998	5,474,783
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998	5,958,446
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998	5,656,286
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-001	Aug 7, 1998	6,024,976

ESTRADIOL; NORETHINDRONE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estradiol and Norethindrone Acetate Drugs

Market Overview

The global market for estradiol and norethindrone acetate drugs is experiencing a significant surge, driven by various factors that influence its growth and financial trajectory. Here’s a detailed look at the market dynamics and the financial outlook for this segment.

Market Size and Growth Projections

The estradiol and norethindrone acetate drug market has witnessed substantial growth in recent years and is anticipated to continue this trend. By 2023, the market had reached a notable value, and projections indicate it will attain even higher values by the end of the forecast period, 2031[3][4].

Segmentation

The market is segmented based on several key factors:

By Type

• The market includes various forms such as tablets, patches, injections, and others. Tablets are a dominant form, given their ease of administration and widespread use[3][4].

By Application

• The primary applications include Hormone Replacement Therapy (HRT), contraception, menopausal symptoms management, and others. HRT is a major driver, as these drugs are commonly used to treat menopausal symptoms and prevent postmenopausal osteoporosis[3][5].

By Geography

• The market is geographically divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America and Europe are significant contributors due to high healthcare spending and a large population of postmenopausal women[1][3].

Market Dynamics

Drivers

• Increasing Prevalence of Menopause: The growing number of women entering menopause is a key driver. Estradiol and norethindrone acetate are widely prescribed to manage menopausal symptoms such as vasomotor symptoms and vaginal atrophy[5].
• Advancements in Healthcare: Improvements in healthcare infrastructure and increased access to medical services are boosting the demand for these drugs.
• Rising Awareness: Greater awareness about the benefits of HRT in preventing osteoporosis and reducing the risk of endometrial hyperplasia is driving market growth[5].

Restraints

• Side Effects and Risks: Common adverse reactions such as back pain, headache, and nausea, along with more serious risks like stroke and deep vein thrombosis, can limit market growth[5].
• Regulatory Scrutiny: Strict regulatory environments and the need for continuous clinical trials to ensure safety and efficacy can act as restraints.

Opportunities

• Emerging Markets: The Asia-Pacific region offers significant growth opportunities due to its large and aging population.
• New Formulations: Development of new formulations such as patches and injections can expand the market by offering more convenient and patient-friendly options[3].

Challenges

• Generic Competition: The presence of generic versions of these drugs can reduce the market share of branded products.
• Economic Factors: Economic downturns can affect healthcare spending, impacting the demand for these drugs.

Financial Trajectory

Revenue Projections

The market is expected to grow at a Compound Annual Growth Rate (CAGR) of around 5.5% from 2022 to 2030, indicating robust financial growth. The revenue is projected to increase significantly, driven by the expanding demand for HRT and other applications[4].

Key Players

Major pharmaceutical companies such as Novartis AG, Teva Pharmaceutical Industries Ltd., Mylan N.V., Allergan plc (AbbVie Inc.), and Pfizer Inc. are key players in this market. These companies are investing heavily in research and development to enhance their product portfolios and expand their market presence[1][3].

Competitive Landscape

The competitive landscape is characterized by intense competition among established and emerging players. Key strategies include new product launches, partnerships, mergers and acquisitions, and regional expansions. The report provides a detailed analysis of the top five companies, their market entry year, and their regional and industry presence[1][3].

Regional Analysis

• North America: This region is a significant contributor due to high healthcare spending and a large population of postmenopausal women.
• Europe: Europe also plays a crucial role, with many countries having well-developed healthcare systems.
• Asia-Pacific: This region is expected to grow rapidly due to its large and aging population, along with improving healthcare infrastructure[1][3].

Economic, Political, and Social Landscapes

The market is influenced by various economic, political, and social factors. Economic stability and government policies supporting healthcare can boost market growth. Social awareness campaigns about menopausal health and the benefits of HRT also play a crucial role[3].

Consumer Behavior

Consumer behavior is a critical factor, with patients increasingly seeking convenient and effective treatments for menopausal symptoms. The preference for combination therapies like estradiol and norethindrone acetate is high due to their comprehensive benefits[5].

Pricing Analysis

Product pricing is a significant factor, with the cost of these drugs varying across different regions. The report includes a detailed pricing analysis, considering factors such as product penetration, national and regional levels, and the dynamics within the primary market and its submarkets[1][3].

Value Chain Scrutiny

The value chain analysis includes an examination of the entire supply chain, from raw material sourcing to end-user delivery. This scrutiny helps in understanding the cost structure, profit margins, and potential bottlenecks in the market[1].

Macro-Economic Analysis

The macro-economic analysis covers broader economic indicators such as GDP growth, inflation rates, and healthcare expenditure. These factors significantly influence the market's financial trajectory and growth prospects[1][3].

Porter's 5 Forces Framework

The Porter's 5 Forces Framework is used to analyze the competitive forces within the market. This includes the threat of new entrants, the bargaining power of suppliers and buyers, the threat of substitute products, and the intensity of competitive rivalry. This framework helps in understanding the market's competitive landscape and potential risks[1].

Key Takeaways

• The estradiol and norethindrone acetate drug market is poised for significant growth driven by increasing demand for HRT and other applications.
• The market is segmented by type, application, and geography, with tablets and HRT being dominant segments.
• Key drivers include the growing prevalence of menopause and advancements in healthcare, while restraints include side effects and regulatory scrutiny.
• Emerging markets and new formulations offer significant growth opportunities.
• Major pharmaceutical companies are key players, with intense competition and strategic investments in R&D.

FAQs

What are the primary applications of estradiol and norethindrone acetate drugs?

The primary applications include Hormone Replacement Therapy (HRT), contraception, and menopausal symptoms management.

Which regions are the most significant contributors to the market?

North America and Europe are significant contributors, while the Asia-Pacific region is expected to grow rapidly.

What are the common adverse reactions associated with estradiol and norethindrone acetate tablets?

Common adverse reactions include back pain, headache, pain in the extremity, nausea, and others.

How is the competitive landscape of the market characterized?

The competitive landscape is characterized by intense competition among established and emerging players, with key strategies including new product launches, partnerships, and regional expansions.

What is the expected CAGR of the estradiol and norethindrone acetate drug market from 2022 to 2030?

The market is expected to grow at a CAGR of around 5.5% from 2022 to 2030.

Sources

1. Market Research Intellect: Estradiol/Norethindrone Acetate Drug Sales Market Size, Scope And ...
2. FDA: LOESTRIN® 21 (Norethindrone Acetate and Ethinyl Estradiol)
3. Market Research Intellect: Estradiol & Norethindrone Acetate Drug Market Size, Scope And ...
4. DataIntelo: Estradiol Norethindrone Acetate Drug Market Research Report 2023
5. DailyMed: ESTRADIOL AND NORETHINDRONE ACETATE tablet